FDA.reportPublic FDA data

NDC 68084-511-11 - Simvastatin

This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.

Product NDC
68084-511
Requested NDC
68084-511-11
Package NDCs from labels
68084-511-11, 68084-511-01
Manufacturer
American Health Packaging
Effective date
2025-08-25
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Simvastatin - American Health PackagingAmerican Health Packaging2025-08-25HUMAN PRESCRIPTION DRUG LABEL
National Council for Prescription Drug Programs indexing - billing unitNational Council for Prescription Drug Programs2012-07-24Indexing - Billing Unit

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68084-511-01Simvastatin100 in 1 BOX, UNIT-DOSETABLET, FILM COATED10013
68084-511-11Simvastatin1 in 1 BLISTER PACKTABLET, FILM COATED113

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68084-511SIMVASTATIN TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]12Current NDC, Legacy NDC, 2 package rows20241010_4bec3923-6221-4b8b-9a72-872a63680de1.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68084-511-01EA - Each68084-511edef15c4-69c3-4ff2-b915-52dfc99d2f3612012-07-24
68084-511-11EA - Each68084-511d975f866-e6b3-4324-9d0f-20b6287920b512012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
SIMVASTATINACTIVE INGREDIENTAGG2FN16EVSIMVASTATIN TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]4
SIMVASTATINACTIVE MOIETYAGG2FN16EVSIMVASTATIN TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]4
ASCORBIC ACIDINACTIVE INGREDIENTPQ6CK8PD0RSIMVASTATIN TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]4
BUTYLATED HYDROXYANISOLEINACTIVE INGREDIENTREK4960K2USIMVASTATIN TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]4
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61USIMVASTATIN TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]4
CITRIC ACID MONOHYDRATEINACTIVE INGREDIENT2968PHW8QPSIMVASTATIN TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]4
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357SIMVASTATIN TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]4
HYDROXYPROPYL CELLULOSE (TYPE H)INACTIVE INGREDIENTRFW2ET671PSIMVASTATIN TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]4
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOSIMVASTATIN TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]4
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XSIMVASTATIN TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]4
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30SIMVASTATIN TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]4
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJSIMVASTATIN TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]4
TALCINACTIVE INGREDIENT7SEV7J4R1USIMVASTATIN TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]4
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPSIMVASTATIN TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]4

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 5 of 121 · 2,415 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Good Instincts Proper Sunscreen SPF 50ZINC OXIDE, TITANIUM DIOXIDEInhabit Brands, Inc82d2af99-7c42-4ce5-94e0-b2ac60b8db1b2026-06-22WarningsExact identifier
unii: 15FIX9V2JP
ESPOIR BE VELVET COVER CUSHIONHOMOSALATE, TITANIUM DIOXIDEESPOIR Corporation54ce2420-4ac0-eb51-e063-6294a90a2de92026-06-21WarningsExact identifier
unii: 15FIX9V2JP
BABIES KIDSSUN PROTECTIONMINERAL SUNSCREENPANERGYTEK USA INC3a554118-b71d-a844-e063-6294a90a699f2026-06-20WarningsExact identifier
unii: 15FIX9V2JP
Rohto Sun and SportHYPROMELLOSE, POVIDONEThe Mentholatum Company8bcc8882-b886-4b55-9bc4-d4b92a41358f2026-06-19WarningsExact identifier
unii: 3NXW29V3WO
Rohto Dual Light ReliefHYPROMELLOSE, POVIDONEThe Mentholatum Company1b597f83-d7f1-cf93-e063-6394a90a99f72026-06-19WarningsExact identifier
unii: 3NXW29V3WO
BoosterviteMULTIVITAMINPureTek Corporation53efbf65-8844-8486-e063-6394a90a51d32026-06-18Warnings, Adverse reactionsExact identifier
unii: PQ6CK8PD0R
Creamy Beige Perfecting Makeup Broad Spectrum SPF 25OCTINOXATE, TITANIUM DIOXIDEMerle Norman Cosmetics, Inc548b7c90-ef97-38ab-e063-6394a90ac6092026-06-18WarningsExact identifier
unii: 15FIX9V2JP
VitramynFOLIC ACIDPureTek Corporationc8af7616-5178-6df0-e053-2a95a90a334d2026-06-18Warnings, Adverse reactionsExact identifier
unii: PQ6CK8PD0R
GlowBiotics Tinted Sunscreen SPF 30ZINC OXIDERum Brands, LLC544dba29-4785-4ab6-e063-6394a90a17b32026-06-16WarningsExact identifier
unii: 15FIX9V2JP
Societe Prime and DefendZINC OXIDE SUNSCREENSociete Clinical Skincare5439bd31-5ee1-9bca-e063-6394a90a748c2026-06-16WarningsExact identifier
unii: 15FIX9V2JP
Societe CoverShield Tinted SPFZINC OXIDESociete Clinical Skincare545efbc4-82d4-f126-e063-6294a90a97102026-06-16WarningsExact identifier
unii: 15FIX9V2JP
Shield by HEALTHY SKIN LAB MD SUNSCREENTITANIUM DIOXIDE, ZINC OXIDEHEALTHY SKIN LAB LIMITED6838b754-9915-48ff-af35-5338dbd06ac42026-06-15WarningsExact identifier
unii: 15FIX9V2JP
ACD ACITRIC ACID MONOHYDRATE, DEXTROSE MONOHYDRATE, AND TRISODIUM CITRATE DIHYDRATETerumo BCT, Ltd.395aec48-198a-4aed-8e38-7accfb3232f92026-06-15Warnings, Adverse reactionsExact identifier
unii: 2968PHW8QP
SFL SUNSCREEN - SOL DEFENSE SPF 30TITANIUM DIOXIDE, ZINC OXIDELifeline Medical, Inc5438c185-31c9-c51e-e063-6394a90ae9ef2026-06-14WarningsExact identifier
unii: 15FIX9V2JP
Sunbetter Daily Mineral Protection Broad Spectrum SPF 75 SunscreenTITANIUM DIOXIDE AND ZINC OXIDESKINBETTER SCIENCE LLC54106748-9810-d3ff-e063-6394a90a5b7a2026-06-12WarningsExact identifier
unii: 15FIX9V2JP
Sunbetter Daily Mineral Protection Broad Spectrum SPF 70 Sheer SunscreenTITANIUM DIOXIDE AND ZINC OXIDESKINBETTER SCIENCE LLC5410e0ed-aed5-3279-e063-6294a90a0c3e2026-06-12WarningsExact identifier
unii: 15FIX9V2JP
Prenate MiniASCORBIC ACID, CHOLECALCIFEROL, .ALPHA.-TOCOPHEROL ACETATE, DL-, PYRIDOXINE HYDROCHLORIDE, FOLIC ACID, LEVOMEFOLATE CALCIUM, CYANOCOBALAMIN, BIOTIN, CALCIUM CARBONATE, FERROUS ASPARTO GLYCINATE, IRON, POTASSIUM IODIDE, MAGNESIUM OXIDE, DOCONEXENT AND LOWBUSH BLUEBERRYAvion Pharmaceuticals, LLC8ab766c2-d554-4141-92b2-fbe038e80c9f2026-06-12Boxed warning, Adverse reactionsExact identifier
unii: PQ6CK8PD0R
Prenate EssentialASCORBIC ACID, CHOLECALCIFEROL, .ALPHA.-TOCOPHEROL ACETATE, DL-, PYRIDOXINE HYDROCHLORIDE, FOLIC ACID, LEVOMEFOLATE CALCIUM, CYANOCOBALAMIN, BIOTIN, CALCIUM FORMATE, FERROUS ASPARTO GLYCINATE, POTASSIUM IODIDE, MAGNESIUM OXIDE, DOCONEXENT AND ICOSAPENTAvion Pharmaceuticals, LLCe5acfb2a-0959-4542-9b4c-790be194d5812026-06-12Boxed warning, Warnings, Adverse reactionsExact identifier
unii: PQ6CK8PD0R
Prenate Elite.BETA.-CAROTENE, ASCORBIC ACID, CHOLECALCIFEROL, .ALPHA.-TOCOPHEROL ACETATE, DL-, THIAMINE MONONITRATE, RIBOFLAVIN, NIACINAMIDE, PYRIDOXINE HYDROCHLORIDE, FOLIC ACID, LEVOMEFOLATE CALCIUM, CALCIUM FORMATE, FERROUS ASPARTO GLYCINATE, CYANOCOBALAMIN, BIOTIN, POTASSIUM IODIDE, MAGNESIUM OXIDE, ZINC OXIDE AND CUPRIC OXIDEAvion Pharmaceuticals, LLC9b79c950-4312-4a53-9e36-fb8e00b053df2026-06-12Boxed warning, Adverse reactionsExact identifier
unii: PQ6CK8PD0R
GUNA-CELLACETYLCARNITINE, L-AMPC-ALPHA-LIPOIC AC-A-TOCOPHEROL-ASCORBIC ACID-CALC CARB-CITRIC AC-COBALAMIN-COLCHICUM-CONIUM-CUPRIC SULF-HERRING SPERM DNA-FERROUS FUMARATE-FOLIC ACID-FUMARIC ACID-KALI ASPARTATE-MANG PHOS-MANG GLUCONATE-MANG PHOS II-PYRUVALDEHYDE-NAT OXALACETICUM-SODIUM PYRUVATE-NIACIN-PANTOTHENIC ACID-PH-PODOPHYLLUM PELTATUM-PYRIDOXINE HYDROCHLORIDE-RIBOFLAVIN-SACCHAROMYCES CEREVISIAE RNA-SELENOMETHIONINE-SUCCINIC ACID-SULFUR-THIAMINE HYDROCHLORIDE-ZINCGuna spa90db80ed-c037-4e8f-a7f6-304a65f9fe222026-06-11WarningsExact identifier
unii: 2968PHW8QP
unii: PQ6CK8PD0R

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.